All rights reserved All commercially distributed Drug Products and Over-The Counter OTC consumer products that require expiration dating shall be labeled with an Expiration Date that is consumer readable. APIs shall be assigned and labeled with expiration dates only if it is registered or required by local regulation. Re-evaluation dating for APIs is outside the scope of this article. Expiration dates must relate to any storage conditions stated on the label. The expiration date assignment format shall be based on the requirements for the product market. For APIs, the Expiration Date of the Blended Batch shall be based on the manufacturing date of the oldest tailings or batch in the blend. For Drug Products Containing reprocessed drug products, the expiration date shall be based on the manufacture date of the oldest reprocessed lot used in the production lot. Where more than one drug product lot with different Manufacture Dates are packaged together e. Maximum Expiration Dating for drug products shall not exceed five 5 years. Extension of Expiration Dating for already manufactured and packaged drug product may be performed based on the following criteria:
Study Questions Drug Expiration Policy
Thrown out, but still usable: July 27, Thrown out, but still usable: The timeline currently is about 2—3 years out, or roughly how long manufacturers believe a product will hold up over time and under stress. Passing this date does not necessarily mean the medicine is suddenly ineffective—it simply means that FDA and manufacturers no longer guarantee its efficacy. Both government and private testing, however, have demonstrated that many “expired” drugs are indeed stable, potent, and viable long beyond their indicated shelf life.
Despite this realization, pharmaceutical industry representatives say it is more important to protect patient safety.
The U.S. Food and Drug Administration on Tuesday extended the expiration date of specific lots of Mylan NV’s EpiPen allergy injectors by four months to mitigate the shortage of the life-saving.
FDA, set out to investigate the efficacy of pharmaceutical drug stockpiles beyond their expiration dates. The results showed that about 90 percent of the drugs were still effective far past their expiration dates. Fifteen years ago, the U. Sitting on a one billion dollar stockpile of drugs and facing the daunting process of destroying and replacing its supply every two to three years, the military began a testing program to see if it could extend the life of its inventory.
The testing, conducted by the U. Food and Drug Administration, ultimately covered more than drugs, prescription and over-the-counter. The results, never before reported, show that about 90 percent of them were safe and effective far past their original expiration date, at least one for 15 years past it. In light of these results, a former director of the testing program, Francis Flaherty, says he has concluded that expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer.
Flaherty notes that a drug maker is required to prove only that a drug is still good on whatever expiration date the company chooses to set. The expiration date doesn’t mean, or even suggest, that the drug will stop being effective after that, nor that it will become harmful. Marketing Issue “Manufacturers put expiration dates on for marketing, rather than scientific, reasons,” says Mr.
Flaherty, a pharmacist at the FDA until his retirement last year. Still, Joel Davis, a former FDA expiration-date compliance chief, says that with a handful of exceptions – notably nitroglycerin, insulin and some liquid antibiotics – most drugs are probably as durable as those the agency has tested for the military.
Do Food Expiration Dates Really Matter
Experts provide a guide to the variety of confusing ‘freshness’ dates on food. Will you sniff this? The approved way lies in a voluntary system of labeling.
Nov 12, · “In , FDA’s Office of Testing and Research examined several EpiPen samples that were beyond their expiration date and the data raised concerns,” Eisenman said in an e-mail.
But according to a new report from ProPublica, most of those drugs are safe and effective for years after the expiration date. For decades, the federal government has stockpiled massive stashes of medication, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency. Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended.
For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates. A study of drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences. To put the magnitude of that return on investment into everyday terms: I suggest reading ProPublica’s entire report, which provides one stunning example after another of bureaucratic cautiousness fueling rational but egregiously wasteful behavior.
Hospitals don’t dispense perfectly safe but expired drugs because that may expose them to regulatory penalties or lawsuits. Pharmaceutical companies don’t push back against the FDA “because regulations make it expensive and time-consuming for manufacturers to extend expiration date.
Most Drug Expiration Dates Are Bogus, and the FDA Knows It
Health Library Drug Expiration Dates: How Accurate Are They? Since , the Food and Drug Administration FDA has required pharmaceutical manufacturers to provide expiration dates on all their products. For the majority of drugs sold in the United States, these dates range from 12 to 60 months from the date they are manufactured.
The accuracy of drug expiration dates has been the subject of much discussion. Since , the FDA has been administering a program called Shelf Life Extension Program (SLEP) for the military. The program tests military stockpiles of drugs to determine stability after the expiration dates have passed.
Currently, EpiPens expire 18 months from date of manufacturing. Initially, the approval was for 20 months, but subsequent data supported 19 months. The company decided to use 18 months, she said. EpiPens are, fortunately, needed only in emergencies. Doctors say questions about the expiration date of the product come up all the time. Epinephrine is an old and cheap medication, but it’s also notoriously finicky. If exposed to light, heat or air, it can degrade, turning rust colored. The FDA-approved label warns that if the liquid in the pen is discolored, it should be discarded: Most were not discolored, but the epinephrine content decreased over time.
Even a sub-optimal dose could be better than nothing in a life-or-death situation, the authors concluded. The study also found that the color did not reliably indicate whether the epinephrine had degraded.
The Expiration Date on Vitamins & Meds
Potassium iodide is a salt, similar to table salt. Its chemical symbol is KI. It is routinely added to table salt to make it “iodized.
The FDA extended expiration dates for certain lots of mg EpiPens in an effort to alleviate product shortages. The agency extended the expiration dates for four months beyond the month approved shelf life that is based on stability data provided by the drugmaker.
Why does eye makeup have a shorter shelf life? The shelf life, or expiration date, of a cosmetic or personal care product is the period during which the manufacturer has determined a product to be best suited for use. There are no regulations or requirements under current U. However, manufacturers have the responsibility to determine shelf life for products as part of their responsibility to substantiate product safety.
Expiration dates are required for over-the-counter OTC drugs. However for OTC drugs without dosage limitations e. In Europe, cosmetic products with a lifespan longer than 30 months must show a “period after opening” POA time. That is, the time in months when the product will remain in good condition after the consumer has used the product for the first time.
A symbol of an open cream jar is usually used instead of words and the time in months can be inside the symbol or alongside it. Although this symbol is frequently present on some U.
Have the Labeling Requirements been Met? No pre-approval of label is required by FDA for products under its jurisdiction. It is the responsibility of the manufacturer or importer of a food to comply with current food labeling regulations. Pre-approval of label by USDA is required for products under its jurisdiction; e.
Apr 21, · The expiration date doesn’t mean, or even suggest, that the drug will stop being effective after that, nor that it will become harmful. “Manufacturers put expiration dates on for marketing, rather than scientific, reasons,” said Mr. Flaherty, a pharmacist at the FDA until his retirement in
Fifteen years ago, the U. The testing, conducted by the U. Food and Drug Administration, ultimately covered more than drugs, prescription and over-the-counter. In light of these results, a former director of the testing program, Francis Flaherty, says he has concluded that expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer. Flaherty notes that a drug maker is required to prove only that a drug is still good on whatever expiration date the company chooses to set.
The expiration date doesn’t mean, or even suggest, that the drug will stop being effective after that, nor that it will become harmful. Flaherty, a pharmacist at the FDA until his retirement last year. Still, Joel Davis, a former FDA expiration-date compliance chief, says that with a handful of exceptions — notably nitroglycerin, insulin and some liquid antibiotics — most drugs are probably as durable as those the agency has tested for the military.
And they acknowledge that expiration dates have a commercial dimension. But they say relatively short shelf lives make sense from a public-safety standpoint, as well. New, more-beneficial drugs can be brought on the market more easily if the old ones are discarded within a couple of years, they say. Label redesigns work better when consumers don’t have earlier versions on hand to create confusion.
From the companies’ perspective, any liability or safety risk is diminished by limiting the period during which a consumer might misuse or improperly store a drug. Now that the FDA has found that many drugs are still good long after they have supposedly expired, why doesn’t it advocate later expiration dates for consumer drugs?
Background[ edit ] Shelf life is the recommended maximum time for which products or fresh harvested produce can be stored, during which the defined quality of a specified proportion of the goods remains acceptable under expected or specified conditions of distribution, storage and display. If the cans look okay, they are safe to use. Discard cans that are dented, rusted, or swollen.
High-acid canned foods tomatoes, fruits will keep their best quality for 12 to 18 months; low-acid canned foods meats, vegetables for 2 to 5 years. Most food is still edible after the expiration date.
The Food and Drug Administration has extended the expiration date for certain lots of Mylan’s EpiPen, an attempt to offset current shortages stemming from a variety of supply and manufacturing issues. The extension of four months beyond the approved month shelf life is based on reviews of the.
Medically reviewed on Jun 11, by L. Anderson, PharmD Patients often have questions about drug expiration dates: Can I safely take a medication if it has reached the drug expiration date? Are there recommendations about the best way to store my medications? Which drugs should never be used past their expiration date? For many patients, these questions arise because medications can be expensive and it is costly to frequently replace expired but unused medications.
What does an expiration date mean? The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication. Drug expiration dates exist on most medication labels, including prescription, over-the-counter OTC and dietary herbal supplements.
FDA extends EpiPen expiration date to ease shortages
Freezing and boiling temperatures break down the chemicals in plastic bottles which can then leak into the liquid. You can freeze and re-freeze them but NOT sparkling water for use in a cooler or ice chest – but do not drink them when thawed see further notes below. Of course, all food and drink products last for a shorter period of time if they are not stored properly.
But remember, UN-like a lot of other drinks , it does not usually have a sell by date because water has an indefinite expiration date.
The reason for this is that both expiration dates and beyond-use dates take into consideration the handling and storage factors of the medication.
You may want to read this page first for background. There is no uniform or universally accepted system used for food dating in the United States. Although dating of some foods is required by more than 20 states, there are areas of the country where much of the food supply has some type of open date and other areas where almost no food is dated. Food expiration date coding is a nightmare for the consumer to interpret. There is no standard. Each vendor decides how they want to do it.
The FDA only has guidelines on labeling a product and the required information. This is different from an expiration date on all food products that the consumer can understand. Food products can be divided into two main categories – refrigerated and canned. Most bakery and pharmacy related food items are “sell by” or “best by” dated, which is easy for you and I to understand.
Some refrigerated and canned manufactures use this form of dating.
Thrown out, but still usable: the myth of drug expiration dates
It is a piece that has been available on the Web for about a year but was brought to my attention recently. It answers a question that I have asked and been asked multiple times. Before I found this, no one had ever given me a straight answer about what the expiration dates on medications mean and how seriously they should be taken. This is an important issue, and I think that psychopharmacologists, if not all practitioners and patients, will find this column immensely helpful. It is well researched, well written, and I wish that I had written it myself.
If a bottle of Tylenol, for example, says something like “Do not use after June ,” and it is August , should you take the Tylenol?
The U.S. Food and Drug Administration (FDA) has announced that a selection of the injectable drugs manufactured by Hospira, Inc., a Pfizer company, may be used passed the labeled expiration date to ease the ongoing critical shortage of critical care injectable drugs, including atropine, epinephrine and .
The box of prescription drugs had been forgotten in a back closet of a retail pharmacy for so long that some of the pills predated the moon landing. Most were 30 to 40 years past their expiration dates — possibly toxic, probably worthless. But to Lee Cantrell, who helps run the California Poison Control System, the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent?
Cantrell called Roy Gerona, a University of California, San Francisco, researcher who specializes in analyzing chemicals. Gerona had grown up in the Philippines and had seen people recover from sickness by taking expired drugs with no apparent ill effects. Pharmacies across the country — in major medical centers and in neighborhood strip malls — routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates.
ProPublica has been researching why the U. One answer, broadly, is waste — some of it buried in practices that the medical establishment and the rest of us take for granted. Overall, the bottles contained 14 different compounds, including antihistamines, pain relievers and stimulants. All the drugs tested were in their original sealed containers. The findings surprised both researchers: